SOUTH SAN FRANCISCO, Calif., July 29 MonogramBiosciences, Inc. (Nasdaq: MGRM) today reported financial results for thequarter ended June 30, 2008.
The Company had revenues of $16.1 million for the second quarter of 2008,66% higher than $9.7 million in the second quarter of 2007. This growth wasdriven by revenue from Trofile(TM) for selecting HIV patients to be treatedwith Selzentry(TM), Pfizer's CCR5 antagonist, and by revenue from use ofMonogram's PhenoSense HIV(TM) resistance test and Trofile in a phase III trialby a pharmaceutical company customer.
Revenue for the six months ended June 30, 2008 was $31.0 million, anincrease of 62% over $19.1 million in the first six months of 2007.
In addition to the reported revenue for the quarter, Monogram recorded asdeferred revenue, the sale of Trofile assays to Pfizer for patient testingoutside of the U.S. and for use in clinical trials. These deferred revenueswere $1.2 million and $2.0 million for the three and six months ended June 30,2008, respectively. This revenue was recorded as deferred revenue due to theaccounting for the Company's collaboration with Pfizer. Had these sales notbeen accounted for as deferred revenue, total revenue on a Non-GAAP basis, forthe three and six months ended June 30, 2008 would have been $17.3 million and$33.0 million, respectively.
Monogram has performed over 8,000 Trofile tests to date for U.S. patientsand revenue from Trofile in the quarter ended June 30, 2008 was $3.7 million.
"Revenues were again at a record level in the second quarter," said AlfredMerriweather, Monogram's Chief Financial Officer. "Gross margin on productrevenues for the second quarter was 54%."
The Company had approximately $26.9 million in cash, cash equivalents andshort-term investments at June 30, 2008. Cash used in operations for thefirst six months of 2008 was $8.4 million.
HIV Tropism and Resistance Testing
Recent significant developments in Monogram's HIV business include:
-- Introduction in June of sensitivity enhancements to Trofile enablingthe identification of X4 virus present at a level as low as 0.3% of the totalviral population, a thirty-fold increase in sensitivity.
-- Presentation in June, at the Drug Resistance Workshop in Sitges, Spain,of data providing clinical validation of optimized patient selection with theenhanced assay format.
-- Establishment of coverage for Trofile by New York and California stateMedicaid programs.
-- Announcement of the availability August 4 of the PhenoSense Integraseassay for assessing resistance to the integrase class of HIV drugs.
-- Extension of Trofile's availability outside of the U.S. to thirteenEuropean countries, Canada, Brazil and Argentina.
"Selecting the right treatment regimens for HIV patients is critical, notonly to assure that each individual drug is appropriate for the individualpatient but also to make sure that the entire regimen is as robust as possibleto protect the other drugs in the patient's regimen from unnecessary exposureto the development of resistance," said William Young, Monogram ChiefExecutive Officer. "The implementation of enhanced sensitivity in Trofile andthe introduction of our resistance test for the integrase class of HIV drugsfurther extend Monogram's industry-leading portfolio of assays for guiding HIVtherapy decisions."
HERmark(TM) Breast Cancer Assay
Recent significant developments for Monogram's HERmark Breast Cancer Assayinclude:
-- Presentation by collaborators at ASCO in June of a study demonstratingthe superiority of HERmark over FISH as a predictor of trastuzumab response("Total HER2 and HER2 Homodimer Levels Predict Response to trastuzumab").
-- Commercial introduction in July of HERmark for assessment of HER2status in patients with breast cancer -- providing a